|
Device | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S091 |
Date Received | 04/29/2008 |
Decision Date | 05/30/2008 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGES TO THE MANUFACTURING TOLERANCE SPECIFICATIONS OF THE WELD LOCATIONS. |